Premier Insights

Data Management & Biostatistics

Premier Insight 247: Forty Percent Savings in Four Weeks: Yeah, We’re That Good

A U.S. pharmaceutical company needed an immediate outsourcing solution to replace an underperforming vendor. Not only was time critical, cost was, too. These new data specialists would be located offshore to reduce the sponsor’s overhead. Oh, and did we mention it had to be done fast?

Functional Service Provider (FSP)

Premier Insight 246: Transfer and Re-Engage: A Powerful Path to Flexibility and Cost Savings

Functional outsourcing can produce significant savings and greatly increase flexibility in assigning resources. But any big change in staffing requires care to avoid personnel disruptions, keep projects on track, and comply with laws governing use of contract employees.

Consulting

Premier Insight 260: The Russian Connection: Recruiting Hard-to-Find Patients from a Specific HLA Subgroup

At first glance, it seemed no more complex than any other global, randomized Phase 3 study. The devil turned up in the details. It’s always been true: every trial is a learning experience. Every one is different, and every one presents new challenges. And we confirmed that Premier Research can field the kind of teams...

Data Management & Biostatistics

Premier Insight 244: Data Management: A Growing Challenge, Made Easier

Premier Research is at the forefront of offering secure file-transfer services for pharma companies. Unlike other providers of secure file hosting, we understand the needs that are specific to the industry — such as giving all trial participants upload and download access while building in firewalls between lab vendors.

Clinical Research: Phase 1 - Phase 4

Premier Insight 250: A Study That Wasn’t Working Until Premier Research Stepped In

A customer called on us to rescue a study that just wasn’t going well. (It happens a lot.) The challenge was to deliver data the company needed to make a go-/no-go decision at a major internal meeting that couldn’t be rescheduled. The problems stemmed, in part, from a failure to communicate between a large, somewhat...

Patient and Stakeholder Engagement

Premier Insight 252: A Novel Treatment That Worked So Well It Almost Derailed the Study

We were testing an autologous chondrocyte transplantation system to repair damaged knee cartilage. The problem was that patients felt great after treatment, and saw no need to make follow-up visits. But the FDA required us to track results for seven years. The challenge: To keep patients involved for seven long years, especially active young patients...

Consulting

Premier Insight 236: Fibromyalgia: Gaining Knowledge of a Little-Understood Disease

Joining in the elusive pursuit of fibromyalgia pain relief, a small pharmaceutical company engaged Premier Research for a Phase III trial following our completion of the product’s Phase II research. The compound under study: a muscle relaxer on the market for decades, repurposed for the possible treatment of fibromyalgia. The sponsor chose Premier Research largely...

Patient and Stakeholder Engagement

Premier Insight 253: Is it Safe or Not? Ask a Panel of Independent Experts

When it comes to study data, not everything can be easily measured and reflected by numbers. In a recent trial of a new occluder device for transcatheter closure of secundum atrial septal defects, the primary efficacy endpoint of defect closure was easy to measure in millimeters of possible residual shunt. However, assessment of the safety...

Patient and Stakeholder Engagement

Premier Insight 255: Merging Science and Nuance to Treat Post-Traumatic Stress Disorder

Patient enrollment is a key challenge in most clinical trials, and studies of drugs to treat post-traumatic stress disorder require an especially nuanced approach to recruiting. The target population of military service members is inherently circumspect, and the conditions that afflict these men and women add greatly to the challenge.

Data Management & Biostatistics

Premier Insight 238: Back On Track: Data Rescue On Pediatric Rare Disease Trial

 Imagine rebuilding the engine in an ambulance carrying a critically ill patient to the hospital. Got it? Then you have a pretty good idea what it took to put this pediatric rare disease trial back on track. A pharma company developing a drug to treat urea cycle disorder struggled with a CRO that was not...